LaGRA Trial in Laparoscopic Cholecystectomy (LaGRA)

January 8, 2018 updated by: Des Toomey, Health Service Executive, Ireland

Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.

This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.

Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing laparoscopic cholecystectomy
  • ASA I, II or III

Exclusion Criteria:

  • Patients that don't consent to be included
  • Allergy to levobupivacaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LaGRA
regional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal
Drug: Levobupivacaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
Other Names:
  • Chirocaine
Placebo Comparator: Placebo
Sham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal
Drug: Placebo
Saline injection to Transversus abdominis plane and rectus sheath
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain score
Time Frame: 6 hours post operatively
Visual analogue pain scores ranging from 0 to 10
6 hours post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid use
Time Frame: Perioperative period including first 6 hours post operatively
Amount (mg) of opioid medication administered
Perioperative period including first 6 hours post operatively
Analgesic use
Time Frame: Perioperative period including first 6 hours post operatively
Type and dose of all non opioid analgesic medications prescribed
Perioperative period including first 6 hours post operatively
Readmission rate
Time Frame: 30 days post operative
Patient readmitted to hospital for any reason
30 days post operative
Daycase rates
Time Frame: Day of surgery
Patient that was planned for daycase but admitted overnight
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Service Executive, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

August 30, 2017

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaGRA-MRHM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Levobupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe